There are many common questions people have when creating Define-XML metadata for their datasets. One of these revolves around how to handle data that can come from multiple sources, such as a CRF or eDT. In the simple case you just create a Value List, and specify the Origin on each Value instead of on the Variable.
Over the last few years our industry has become familiar with CDISC standards. This has largely been driven by regulation, with national regulators such as FDA and PMDA mandating the use of submission standards such as SDTM, SEND and ADaM.
This post shines a spotlight on the lesser known Operational Data Model (ODM) standard, which is often overlooked as it's not required by any regulators. Why should you be interested in it? Because it can be used as a standard way to define forms, independent of the data collection system. These forms can then be turned into organizational standards, driving data quality and consistency. Finally they can be used to drive your data collection system. In short, they put you in control.
With the right tools in place sponsors and CROs can define data collection standards while remaining flexible in their EDC choice. They can also take control of their EDC build to save time and money. Standardizing your data collection means greatly reduced future study build cost due to re-use and increased consistency between studies.
Because the focus of CDASH (Clinical Data Acquisition Standards Harmonization) is on data collection, not data reporting, it works a little differently from the rest of the CDISC content standards. Since there is a disconnect between collection and reporting, the point of CDASH is to bridge that gap by showing how data should be collected, minimizing the disparity with reporting.
In last week’s blog, we looked at the SDTM mapping process and ended on the cliffhanger of the supplemental qualifier. These tricky little tidbits are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard. Let’s look at them in a little more detail.
Any data managers who have attempted to annotate a non-CDASH CRF with SDTM variables will know that it is somewhat of an ordeal.
Case report forms (CRFs) are not exempt from the watchful eye of standards; they collect data from clinical research studies in a structured fashion. Their credibility exists primarily because they are regulated by peer reviewed standards.
Recently, there have been comments about the Lilly ODM library no longer being available on the CodePlex website.
Last week, Mark blogged about the increasing wave of external standards coming our way from NCI, CDISC, TransCelerate and more. So, with these new standards, there obviously comes a need to harmonize data processes and map these to CDISC SDTM in a consistent way. Companies are wondering about the best ways to achieve this consistency and standards management for Controlled Terminology, in particular.